Regulatory Manager - Sanofi - Budapest

About the job

At Sanofi CHC, we have one shared mission– we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come. Everything we do is centered around people – our consumers, our customers, healthcare professionals, and our employees – across the world.

We are on an exciting journey as we have created a fully standalone CHC Business Unit (separating the Business Unit from our Pharma company heritage and processes), to create an agile, consumer-centric and responsive organization to deliver our ambition: to become the best Fast Moving Consumer Health (FMCH) company in and for the world.

Regulatory Manager

The Regulatory Manager supports regulatory compliance for marketed products by means of a correct and timely handling of all CMC regulatory activities for the CMOs (Contract Manufacturing Organisations) and related assigned drug products.

The position holder manages regulatory activities linked to change controls for the assigned CMOs including updating of CMC files. The Regulatory Manager also supports product license maintenance and site registration.

The Regulatory Manager ensures the role of regulatory expert for all regulatory topics and projects for the assigned CMOs

Regulatory Compliance

Supports batch release by following submission and approval status to ensure the product regulatory compliance on related CMOs.

Ensures that the CMC dossier is in line with manufacturing and control procedures at the related CMO and with dossiers approved by Health Authorities.

Guarantees compliance with regulatory and corporate requirements for all regulated activities

Evaluates the regulatory compliance of current dossiers versus manufacturing site practices and current regulations and highlights discrepancies:

Defines the regulatory strategy for compliance and the preparation of variation files.

Follows additional work and/or changes required for compliance.

Change Control

Evaluates change controls:

Evaluates the regulatory impacts of changes during the product life cycle in accordance with the Change Control procedure in force,

Defines the regulatory strategy

Follows the submissions and approvals of variation files in each country.

Product Quality Review

Ensures the review of the regulatory part of the Product quality review of the portfolio.

CMC Documentation management

Writes, updates and / or reviews CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submission

Coordinates CMC writing performed by another entity (internal or external)

Optimizes the content of CMC dossiers to facilitate the management of future changes by checking the relevant level of information to be provided

Prepares with contribution of CMO experts the answers to questions from Health Authorities

Supports Marketing Authorisations worldwide (territory extensions, renewals, site registrations and transfers…) by writing and / or reviewing the corresponding CMC documents/dossiers and collecting GMP related documents

Consolidates regulatory activities in a planning tool in liaison with other regulatory affairs functions

Transversal activities

Acts as the regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs for EM CHC Frankfurt Quality

Supports business units in the assigned region in the management of new business opportunities and product launches.

Delivers against key Quality KPIs/metrics and drives results that ensure site compliance on a consistent and continuous basis.

Implements the appropriate company tools to manage all his/her activities

Contributes to site inspections and audits as appropriate

Writes, Reviews and signs-off documents like SOPs, technical reports or other related documents

Management

Contributes to the RSO knowledge base and supports development of the organization

Background and Experience

  • Scientific studies in pharmacy, Ph.D. in pharmaceutical sciences preferred, Chemical or biochemical engineer.

  • Practical experience in pharmaceutical industry in GMP environment (Quality Assurance and Development or Production / Quality Control). Experience in establishing and maintaining GMP and regulatory compliance.

  • Knowledge of national and international current drug regulations (incl. EU, FDA)

  • Practical experience in CMC writing and/ or Regulatory Affairs business.

  • Know-how of contractual manufacturing topics is an advantage

  • Strong oral and written communication skills and interpersonal skills in international environment

  • Good English language skills to effectively negotiate and communicate verbally and in writing.

When joining our team, you will experience:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team

  • An attractive, market-oriented salary and cafeteria benefits

  • Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days

  • Work from an "Office of the Year 2020" finalist office

  • Collective life and accident insurance

  • Yearly medical check-up

  • An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks

  • Your own career path within Sanofi. Your professional and personal development will be supported purposefully

  • Practice your language skills within our "Language Club"

  • Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

#Sanofi #WeNeverSettle

#SanofiCareers

#PursueProgress

#DiscoverExtraordinary

#joinsanofi

#careerswithpurpose

#SBSBUDAPEST

#LI-EUR

#LI-CHC

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.